This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Change to the delivery system trigger-wire coating facility and updates to the acceptance criteria used in testing of the trigger wires.
| Device | Zenith® Dissection Endovascular System |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | WILLIAM COOK EUROPE APS |
| Date Received | 2021-11-15 |
| Decision Date | 2021-12-15 |
| PMA | P180001 |
| Supplement | S003 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WILLIAM COOK EUROPE APS sandet 6, Dk-4632 bjaeverskov |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180001 | Original Filing | |
| S006 | 2022-06-06 | Real-time Process |
| S005 | 2022-05-05 | Special (immediate Track) |
| S004 | 2022-03-18 | Special (immediate Track) |
| S003 | 2021-11-15 | 30-day Notice |
| S002 | 2020-10-02 | Normal 180 Day Track No User Fee |
| S001 | 2019-10-01 | Normal 180 Day Track No User Fee |